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Spotchem D-00 Qr (sd-9811)
EUDAMEDClass IVD General (EU MDR)
Ref 104933Ref 107507
Identity
- Trade Name
- SPOTCHEM D-00 QR (SD-9811) EUDAMED
- Device Name
- SPOTCHEM D-00 QR (SD-9811) EUDAMED
- Model / Reference
- 104933 EUDAMED107507 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-104933MU EUDAMED04987486034605 EUDAMED
- Basic UDI-DI
- B-104933MU EUDAMED4987486BC0107507GW EUDAMED
- EMDN Code
- W0201030180 MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Germany EUDAMEDIreland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Spotchem D-00 Qr (sd-9811) by ARKRAY Factory, Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-104933MU | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-104933MU | Class IVD General | Active |
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Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (2)
- EUDAMED 4a31233a-3048-419e-bb19-dd6f078159e0 61 fields · synced Jul 8, 2026
- EUDAMED 68e19406-9c17-4487-9d86-e2cf68595ce7 61 fields · synced May 17, 2026